Trial · NCT00873093
Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT00873093, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Trials, record NCT00873093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00873093
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT number
- NCT00873093
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Lymphoblastic Lymphoma, T-cell Adult Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia
- Interventions
L-asparaginase, doxorubicin hydrochloride, therapeutic hydrocortisone, vincristine sulfate, cytarabine, prednisone, bortezomib, pegaspargase, methotrexate, etoposide phosphate, cyclophosphamide, filgrastim, leucovorin calcium, laboratory biomarker analysis, High Dose MTX
- First posted
- 2009-04-01
- Last updated
- 2017-01-27
- Results first posted
- 2017-01-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy | The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy. | The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. |
| Primary | Event Free Survival | 4 months after enrollment | Percentage of patients who were event free at 4 months |
| Primary | Toxic Death Rate | 4 months | The proportion of toxic death rate among all eligible patients. |
| Primary | Severe Adverse Events (SAE) Rate. | 4 months | The proportion of SAE rate among all eligible patients |
| Secondary | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 | End of Block 1 (Day 36 of Block 1) of re-induction therapy | Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 1. |
| Secondary | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 | End of Block 2 (Day 36 of Block 2) of re-induction therapy | Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 2. |
| Secondary | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 | End of Block 3 (Day 36 of Block 3) of re-induction therapy | Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 3. |
| Other | NF-kB Activity | Up to 5 years | NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. |
| Other | Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots | Up to 5 years | Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation. |
| Other | Change in Stem Cell Percentage | Baseline to post-treatment with bortezomib | Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy | The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy. | The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1. | Percentage of participants | NUMBER |
| PRIMARY | Event Free Survival | 4 months after enrollment | The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1. | Percentage of participants | NUMBER |
| PRIMARY | Toxic Death Rate | 4 months | The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2. | percentage of participants | NUMBER |
| PRIMARY | Severe Adverse Events (SAE) Rate. | 4 months | The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2. | percentage of participants | NUMBER |
| SECONDARY | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 | End of Block 1 (Day 36 of Block 1) of re-induction therapy | The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3. | percentage of participants | NUMBER |
| SECONDARY | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 | End of Block 2 (Day 36 of Block 2) of re-induction therapy | The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3. | percentage of participants | NUMBER |
| SECONDARY | Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3 | End of Block 3 (Day 36 of Block 3) of re-induction therapy | The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | NF-kB Activity | Up to 5 years | These were for correlative biology studies and the data were not collected in COG database. | ||
| OTHER_PRE_SPECIFIED | Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots | Up to 5 years | These were for correlative biology studies and the data were not collected in COG database. | ||
| OTHER_PRE_SPECIFIED | Change in Stem Cell Percentage | Baseline to post-treatment with bortezomib | These were for correlative biology studies and the data were not collected in COG database. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 72.2 | Percentage of participants | ||
| Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 63 | Percentage of participants | ||
| Event Free Survival | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 68.5 | Percentage of participants | ||
| Event Free Survival | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 37.8 | Percentage of participants | ||
| Toxic Death Rate | Overall | 2.1 | percentage of participants | ||
| Severe Adverse Events (SAE) Rate. | Overall | 8.2 | percentage of participants | ||
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 35.4 | percentage of participants | ||
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 25 | percentage of participants | ||
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 66.7 | percentage of participants | ||
| Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2 | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 42.1 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr | 4 | |
| Overall Study | STARTED | Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr | 62 | |
| Overall Study | STARTED | Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs | 49 | |
| Overall Study | STARTED | T-cell ALL (Chemotherapy) | 23 | |
| Overall Study | STARTED | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | 10 | |
| Overall Study | COMPLETED | Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr | 3 | |
| Overall Study | COMPLETED | Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr | 35 | |
| Overall Study | COMPLETED | Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs | 33 | |
| Overall Study | COMPLETED | T-cell ALL (Chemotherapy) | 12 | |
| Overall Study | COMPLETED | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,270
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs | 3 | 4 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 41 | 61 | 47 |
| other | Anemia | Blood and lymphatic system disorders | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 27 | 49 | 29 |
| other | Anemia | Blood and lymphatic system disorders | T-cell ALL (Chemotherapy) | 17 | 22 | 17 |
| other | Anemia | Blood and lymphatic system disorders | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | 7 | 10 | 7 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs | 0 | 4 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 0 | 61 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 0 | 49 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | T-cell ALL (Chemotherapy) | 1 | 22 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | 0 | 10 | 0 |
1 to 10 of 1,270Source ClinicalTrials.gov
See all 1,270 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs | ||
| Total, all-cause mortality | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | ||
| Total, all-cause mortality | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | ||
| Total, all-cause mortality | T-cell ALL (Chemotherapy) | ||
| Total, all-cause mortality | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | ||
| Total, other adverse events | Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs | 4 | 4 |
| Total, other adverse events | Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs | 58 | 61 |
| Total, other adverse events | Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs | 44 | 49 |
| Total, other adverse events | T-cell ALL (Chemotherapy) | 21 | 22 |
| Total, other adverse events | T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) | 9 | 10 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00873093
GET https://conductscience.org/api/trials/v1/NCT00873093/events?page=2